Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Fructose Intolerance Test Device
- Model numbers
- EAN: 616612787323, SKU: 2B120, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
The Fructose Intolerance Test is a diagnostic device intended to assess fructose intolerance. The recall concerns distribution of the device without premarket approval or clearance in the United States.
Why This Is Dangerous
The device was distributed without FDA premarket approval or clearance, a regulatory violation that may affect safety assessments. The recall emphasizes stopping use and following manufacturer instructions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and clinicians who received the device may be affected by regulatory noncompliance. There were no injuries reported in the recall notice. Immediate action advised.
Practical Guidance
How to identify if yours is affected
- Verify brand: GET TESTED INTERNATIONAL AB
- Check model numbers: EAN 616612787323 or SKU 2B120
- Confirm lot/serial: All Lots
- If affected, stop using the device.
Where to find product info
Packaging, recall notification letter, and any accompanying documentation.
What timeline to expect
Not specified. Typical recall processing may take 4-6 weeks.
If the manufacturer is unresponsive
- Contact GET TESTED INTERNATIONAL AB for instructions and refunds if applicable
- If the company is unresponsive, file a complaint with the FDA recall portal.
How to prevent similar issues
- Always verify that medical devices have FDA premarket clearance before distribution or sale.
- Check the FDA database for PMA status and regulatory approvals.
- Buy medical devices only from reputable sources and retain purchase records.
Documentation advice
Keep the recall letter, product packaging, model numbers, lot numbers, dates of purchase, and all correspondence with the manufacturer.
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Product Details
Model numbers: EAN 616612787323; SKU 2B120; UDI-DI: None; Lot/Serial Number: All Lots. Sold: US Nationwide distribution. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers: EAN 616612787323; SKU 2B120
- No injuries reported
- Stop use and follow manufacturer instructions
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Safety Guide
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